Ellen Scordino’s Post

#FDARegulatoryNewsandTrends: #FDA guidance to extend policy for certain device modifications without regulatory submission; #CDER publishes environmental impact review #ICMRA #ExportCertificates #ClinicalTrials #CBER

Attended the @IMAPAC Biomanufacturing 5.0 conference and learned about two CMC development tools worth using: the Clinton Go-to-market Toolbox and the soon-to-be-launched CEPI CMC Framework. #biomanufacturing #CMCdevelopment #conferencehighlights

💡 Did you know? The FDA recently published a draft guidance regarding the quantity and distribution of testing samples for bioavailability and/or bioequivalence testing. According to this draft guidance, sponsors and contract research organizations (CROs) must reserve 30 single-dose or 3 multi-dose units for each test and reference product in the original container across all testing sites with at least 1 unit in the original container. The guidance applies to applicants submitting NDAs, ANDAs, supplemental applications, and CROs doing bioavailability or bioequivalence studies. 📖 Read the full text ➡️ https://lnkd.in/gRv3H65 #FDA #guidance #bioequivalence #drugdevelopment #ANDA

Get quick insights on the global life sciences Regulatory landscape. Follow Freyr Regulatory Roundup for a weekly dose of Regulatory information. This week, we have covered updates from #healthauthorities like #FDA, #PMDA, and #ANVISA. https://lnkd.in/gctsyvP5   #LifeSciences #RegulatoryIntelligence #FreyrSolutions #RegulatoryRoundup

At the 2024 IPEC-Americas Excipient World conference held in May, CDER Compliance Officer Matthew Dionne discussed FDA’s work to counter the risk of diethylene and ethylene glycol (DEG/EG) contamination. After a brief reflection on his public health service, Dionne addressed: • FDA’s regulatory authority and enforcement tools • DEG/EG contamination events • FDA’s actions in response to the events, and • compliance actions related to FDA’s high-risk components initiative. Read More: https://lnkd.in/eQpr767M For information on recent global CMC/GMP developments, see IPQ’s “Updates in Brief:” https://lnkd.in/eFMTc5Cy   For a look at drug product recalls included in FDA’s weekly enforcement reports, visit IPQ’s recalls page: https://lnkd.in/erwpmUni   Subscribers can also read summaries and click through to recently issued FDA warning letters: https://lnkd.in/e8ppjyv7   If your organization is an IPQ subscriber or partner, you may create a personal username and password. See how: https://lnkd.in/d56q2Ph2   Login today!

With the Chevron Doctrine getting overturned, what does this mean for the healthcare industry? STAT offers a comprehensive overview encompassing what we can expect in the coming months. Here's a quick summary: While it shouldn't pause the individual drug approval process, it could open up many of the agency’s regulatory efforts to legal challenge. It's taking a mostly predictable process and turning it into a world of uncertainty. #FDA #FutureOfHealthcare #ChevronDoctrine

Still in the works, talk of removing the #Interchangeabilty designation to increase #Biosimilar uptake. #POTUS Biden cites "confusion' and "misunderstanding" as it relates to efficacy and safety under current statutes, as part of the rationale to do away with the classification. https://lnkd.in/e9e_d_Qh #Biosimilars #Interchangeability #USFDA #Regulatory #Competition

Not to be missed, these townhalls are so valuable not just to understand the Agency’s current thinking but also to get insights into how companies have approached certain topics to date and their acceptability.

🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory

To accommodate revisions to the European Commission’s Annex 1 regulatory framework, many CDMOs are retrofitting existing fill lines to meet updated environmental monitoring standards. For sponsors assessing different manufacturing partners, consider the impact of working with a CDMO who designed their fill line with Annex 1 specifications as a guide.